A Phase I Study of JSKN021 in Advanced Solid Tumors

August 24, 2026 updated by: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors

This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
199

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • Tumor Hospital of Guangxi Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Xuzhou Central Hospital
    • Shandong
      • Jining, Shandong, China
        • Recruiting
        • Affiliated Hospital of Jining Medical College
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntarily participate and sign the informed consent form.
  2. Age ≥ 18 years old, male or female.
  3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  4. Expected survival ≥ 3 months.
  5. Histologically or cytologically confirmed malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.
  6. At least one measurable lesion at baseline according to RECIST 1.1 criteria.
  7. Adequate organ function.
  8. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
  9. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
  10. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
  11. Adequate washout period of previous therapy before the first dose.

Exclusion Criteria:

  1. Complicated with other malignant tumors within 3 years before the first dose.
  2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
  3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
  4. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
  5. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
  6. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
  7. Uncontrolled infection.
  8. Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
  9. Toxicity of previous anti-tumor treatment has not fully or partially recovered.
  10. Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
  11. Pregnant and/or lactating women, or planning to become pregnant during the study period.
  12. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose escalation cohort 2
Drug: JSKN021
JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose escalation cohort 3
Drug: JSKN021
JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose escalation cohort 4
Drug: JSKN021
JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose escalation cohort 5
Drug: JSKN021
JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose escalation cohort 6
Drug: JSKN021
JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose escalation cohort 1
Drug: JSKN021
JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose optimization cohort 1
Drug: JSKN021
JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose optimization cohort 2
Drug: JSKN021
JSKN021 administered intravenously at selected dose levels according to protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021)
Time Frame: From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc.; abnormalities in physical examinations, laboratory tests, electrocardiograms, and other safety measures.
From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
Dose-limiting toxicity (DLT)
Time Frame: 21 days from the first dose
Incidence of dose-limiting toxicity (DLT) in each dose group.
21 days from the first dose
Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021.
Time Frame: Up to 24 months
Based on safety and efficacy data.
Up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to 24months
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1）
Up to 24months
Duration of response (DoR)
Time Frame: Up to 24months
Duration of response (DoR) assessed according to RECIST v1.1.
Up to 24months
Disease control rate (DCR)
Time Frame: Up to 24months
Disease control rate (DCR) assessed according to RECIST v1.1.
Up to 24months
Progression-Free Survival (PFS)
Time Frame: Up to 24months
Progression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression or death due to any cause (whichever occurs first).
Up to 24months
Overall survival(OS)
Time Frame: Up to 24months
Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.
Up to 24months
Immunogenicity
Time Frame: Up to 24months
Incidence and titer changes of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs, if applicable)
Up to 24months
Maximum concentration (Cmax) of JSKN021
Time Frame: Up to 24months
Maximum concentration (Cmax) of JSKN021
Up to 24months
Time to maximum concentration (Tmax) of JSKN021
Time Frame: Up to 24 months.
Time to maximum concentration (Tmax) of JSKN021
Up to 24 months.
Trough concentration (Ctrough) of JSKN021
Time Frame: Up to 24 months
Trough concentration (Ctrough) of JSKN021
Up to 24 months
Area under the concentration-time curve of JSKN021
Time Frame: Up to 24 months
Area under the concentration-time curve of JSKN021
Up to 24 months
Volume of distribution (V) of JSKN021
Time Frame: Up to 24 months
Volume of distribution (V) of JSKN021
Up to 24 months
Elimination half-life (t1/2) of JSKN021
Time Frame: Up to 24 months
Elimination half-life (t1/2) of JSKN021
Up to 24 months
Clearance (CL) of JSKN021
Time Frame: Up to 24 months
Clearance (CL) of JSKN021
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JSKN021-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared. The informed consent form does not include provisions for sharing de-identified participant-level data with researchers outside the study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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